PDS Biotech's Immunocytokine ADC Shows 78% Response Rate in Colorectal Cancer Trial
Key Insights
PDS Biotech (search)'s PDS01ADC (search) achieved a 77.8% objective response rate in colorectal cancer (search) patients with liver metastases, compared to 35% in a parallel trial without the drug.
The investigator-led Phase II study showed an 85% two-year survival rate for PDS01ADC (search)-treated patients versus 40% in the control group.
Median progression-free survival was not reached at 13.1 months follow-up for PDS01ADC (search) patients, while the parallel trial showed 8.1 months PFS.
PDS Biotech (search)'s tumor-targeting fused antibody drug conjugate (ADC) has demonstrated remarkable efficacy in treating colorectal cancer (search) patients, with the company's stock surging nearly 25% following the release of promising Phase II trial results.
Strong Response Rates in Heavily Pre-treated Patients
In an investigator-led Phase II study (NCT05286814), PDS01ADC (search) achieved a 77.8% objective response rate (ORR) according to RECIST v1.1 criteria after six months in patients with colorectal cancer (search) and liver metastases. This represents a substantial improvement over the 35% ORR observed in a parallel trial without PDS01ADC.
The clinical trial, led by Dr. Jonathan Hernandez, MD, Investigator in the Surgical Oncology Program at the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), enrolled patients who had previously been treated with at least one line of chemotherapy and had failed prior treatment. The study combined subcutaneous injection of PDS01ADC (search) with floxuridine (FUDR), delivered via a hepatic artery infusion pump (HAIP).
Impressive Survival Outcomes
The survival data from the study showed particularly encouraging results. The 24-month survival rate was approximately 85% in patients treated with PDS01ADC (search), compared with 40% in the parallel trial. Additionally, median extrahepatic progression-free survival (PFS) was not reached at the minimum follow-up of 13.1 months, while the parallel trial without PDS01ADC showed a PFS of 8.1 months.
The study included 22 patients, with a two-year survival rate exceeding 80% for those treated with PDS01ADC (search) versus 35% in the control group.
Novel Immunocytokine Approach
PDS01ADC (search) is a tumor-targeted immunocytokine designed to deliver Interleukin-12 (search) (IL-12 (search)), a potent immune-activating agent, directly to the tumor while minimizing exposure to the rest of the body. This approach aims to harness the immune system's power against cancer while reducing the significant side effects that have historically limited traditional recombinant cytokine therapies.
Dr. Frank Bedu-Addo, CEO of PDS Biotech (search), commented on the results: "Despite many meaningful advances in oncology, metastatic colorectal cancer (search) remains an area of significant unmet need. These early results showing strong tumor response rates and promising patient survival are encouraging and support our approach of subcutaneously administering PDS01ADC (search) to activate the immune system against the cancer. We believe these findings represent a meaningful step toward more precise immune-based treatments without the significant side effects that have historically limited traditional recombinant cytokine therapies."
Market Impact and Broader Context
The positive trial data caused PDS Biotech (search)'s stock to rise 23.4% from a market open of $1.07 to a high of $1.32 on April 15, with shares trading up 25.47% at $1.33 according to recent market data.
Colorectal cancer (search) represents a significant global health burden, being the third most common cancer worldwide with nearly two million new incident cases diagnosed and 900,000 deaths associated with the disease annually. Of these global cases, 10% have a BRAF V600E (search) gene mutation implicated in carcinogenesis pathways and carry a poor prognosis compared to other subtypes of colorectal cancer, such as KRAS mutations.
The company has also presented encouraging early results from an NCI-led trial investigating PDS01ADC (search) in prostate cancer (search) at the AACR special conference on prostate cancer research, suggesting potential broader applications for the immunocytokine approach.